This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 6, 2012
Last updated: January 23, 2017
Last verified: January 2017
This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin secretory burst mass

Secondary Outcome Measures:
  • Insulin secretory pulse mass, amplitude, frequency and regularity
  • Insulin secretion
  • Glucagon response
  • Gastric emptying rate
  • Adverse events

Enrollment: 11
Study Start Date: September 1999
Study Completion Date: December 1999
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: liraglutide
A single dose injected subcutaneously (under the skin)
Other Name: NNC 90-1170
Placebo Comparator: Placebo Drug: placebo
A single dose injected subcutaneously (under the skin)


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
  • BMI (Body Mass Index) between 24 and 35 kg/m^2 (both inclusive)
  • Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
  • Anti-GAD (glutamic acid decarboxylase) negative

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Receipt of any investigational drug within three months prior to this trial
  • Recurrent severe hypoglycaemia as judged by the investigator
  • Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
  • Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
  • with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
  • Liver or renal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01507311

Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01507311     History of Changes
Other Study ID Numbers: NN2211-1219
Study First Received: January 6, 2012
Last Updated: January 23, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on August 16, 2017